Conjugated Hyperbilirubinemia and Pulse Oximetry

(Study stopped due to insufficient personnel required to conduct trial.)

Sponsor:

Emory University

ClinicalTrials.gov Identifier:

NCT00741117

First Posted: August 26, 2008

Last Update Posted: March 6, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this study is to determine if higher levels of bilirubin in the blood of people with liver disease affects how accurate a pulse oximeter machine is able to measure the concentration of oxygen in the blood. Previous studies have reported conflicting results regarding the affect of high levels of bilirubin in the blood on the accuracy of the pulse oximeter reading. Initial studies showed an underestimation of the oxygen concentration in the presence of elevated bilirubin. Subsequent studies have suggested that high levels of bilirubin in the blood do not influence the accuracy of the pulse oximeter machine. However, recent reports in bone marrow transplant literature and our personal observations in patients with liver disease suggest that high bilirubin levels are associated with an overestimation of the oxygen concentration as measured by the pulse oximeter machine.

Low Bilirubin Group: subjects with a bilirubin level less than or equal to 10 mg/dl

Procedure: Arterial Blood Gas

One blood gas sample will be obtained from an artery in the arm.

Other Name: ABG

Procedure: Pulse Oximetry Machine

A pulse oximetry machine will be used at one time point to obtain an oxygen saturation reading. This is done by placing a clip onto the finger. The pulse oximetry value displays on the pulse oximeter machine within seconds.

Other Name: Pulse Ox

Procedure: Direct and Indirect Serum Bilirubin Measurement

One tube of blood will be drawn from a vein in the arm at one timepoint to measure the direct and indirect serum bilirubin levels.

Other Name: hepatic function panel

Active Comparator: Medium Bilirubin Group

Medium Bilirubin Group: subjects with a bilirubin level from 11mg/dl to 30 mg/dl

Procedure: Arterial Blood Gas

One blood gas sample will be obtained from an artery in the arm.

Other Name: ABG

Procedure: Pulse Oximetry Machine

A pulse oximetry machine will be used at one time point to obtain an oxygen saturation reading. This is done by placing a clip onto the finger. The pulse oximetry value displays on the pulse oximeter machine within seconds.

Other Name: Pulse Ox

Procedure: Direct and Indirect Serum Bilirubin Measurement

One tube of blood will be drawn from a vein in the arm at one timepoint to measure the direct and indirect serum bilirubin levels.

Other Name: hepatic function panel

Active Comparator: High Bilirubin Group

High Bilirubin Group: subjects with a bilirubin level greater than or equal to 30 mg/dl

Procedure: Arterial Blood Gas

One blood gas sample will be obtained from an artery in the arm.

Other Name: ABG

Procedure: Pulse Oximetry Machine

A pulse oximetry machine will be used at one time point to obtain an oxygen saturation reading. This is done by placing a clip onto the finger. The pulse oximetry value displays on the pulse oximeter machine within seconds.

Other Name: Pulse Ox

Procedure: Direct and Indirect Serum Bilirubin Measurement

One tube of blood will be drawn from a vein in the arm at one timepoint to measure the direct and indirect serum bilirubin levels.

Other Name: hepatic function panel

Eligibility

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients with established liver disease or dysfunction, as determined by abnormal liver function tests, imaging, or biopsy

Exclusion Criteria:

Patients with unconjugated hyperbilirubinemia, which could be associated with elevations in carboxyhemoglobin